Kornimate/medical-research-clean huggingface dataset:
randomized,study of apriso 375 mg versus the approved apriso 375 mg capsules in healthy male and female subjects

Conditions: Ulcerative Colitis

Summary: the objective of this study is to evaluate and compare the bioavailability of mesalamine

the objective of this study is to evaluate and compare the bioavailability of mesalamine and therefore to assess the bioequivalence of 375 mg aprisotm extended-release capsule manufactured at a new site versus the approved 375 mg aprisotm extended-release capsule after a single oral dose administration under fasting conditions.

Eligibility criteria:
inclusion criteria: * healthy male or female, at least 18 years of age * body mass index (bmi) between18.5 and below 32.0 kg/m2 (inclusive) * healthy as determined by a responsible and experienced physician, based on a medical evaluation including medical history, physical examination, ecg and laboratory tests exclusion criteria: * any contraindication to mesalamine according to the applicable labeling
sleep apnea and tromboembolic disease

Conditions: Sleep Apnea Syndromes; Venous Thromboembolism

Summary: there is some evidence for a hypercoagulable state in sleep apnea-hipopnea syndrome (sahs), which could play a role in the increased cardiovascular morbility and mortality. respiratory alterations (hypoxia, hypoxia- reoxygenation) and sleep fragmentation that these patients suffer during the sleep may induce modifications in clotting-fibrinolisis factors that may be a risk factor for venous thromboembolism (vte). objectives:to calculate and compare the prevalence of sleep apnea-hipopnea syndrome in patients with venous thromboembolism with a gender, aged and bmi matched control group. assessment of the association between sahs and other risk factors for vte. to compare clotting- fibrinolisis patterns, sleep parameters, blood pressure and pulmonary arterial obstruction index in patients with sahs and vte and those ones without sahs.

design: case-control study. methods: 133 sahs patients and 133 controls will be studied. the study includes: a) medical history; b) anthropometric variables (weight, height, body mass index, mallampati index); c) sleepiness tested by epworth scale; d) london chest activity of daily living scale; e) conventional polysomnography (psg); f) testing: clotting-fibrinolisis factors (factor v, vii, viii; c and s protein, plasminogen tissular activator (t-pa) and inhibitor of plasminogen activator (pai-1); g) d-dimer and thrombin-antithrombin iii complex; h) basic biochemical profile and hemograma; i) pulmonary artery obstruction index.

Eligibility criteria:
inclusion criteria: * case group: * pulmonary embolism diagnosed by ct pulmonary angiography. * control group: * randomly selected from among patients in two primary health care centers in mallorca without tromboembolic disease exclusion criteria: * refusal to sign informed consent. * expected survival less than 12 months * long-term oxygen therapy * hospital admission in the previous two months. * familiar thrombophilia

Keywords: sleep apnea venous thromboembolism coagulability coagulation factors hypoxia
african cancer genome: gmd

Conditions: Breast Cancer; Prostate Cancer

Summary: the goal of this study is to develop a comprehensive characterization of genetic and molecular drivers of breast and prostate cancer in individuals of african ancestry. the study is conducted by the african caribbean cancer consortium (ac3) and involves the recruitment of patients from nine international ac3 research sites in the bahamas, barbados, benin, burkina faso, haiti, jamaica, kenya, namibia, and trinidad and tobago, and the us. the main questions are to: molecularly characterize genomic changes in the african cancer genomes of the breast and prostate and identify the effects of social determinants of health and lifestyle factors on mutational landscape. black individuals that have been diagnosed with pathologically confirmed prostate or breast cancer will be included. detailed social determinants of health survey, blood and archived ffpe tissues will be collected. (tier 1) all patient tissues will be subject to ihc for receptor status (er, ar, pr her2/neu). all patients with available germline dna from blood will receive genetic screening using a commercial gene panel testing. (tier 2) patient samples with a negative genetic screening will be subject to whole exome sequencing or banked for later rna or methylation sequencing.


Eligibility criteria:
inclusion criteria: * male or female patients, 18-85 years of age, diagnosed with a pathologically confirmed cancer at any stage at diagnosis. participant can have a history of a previous cancer we will control for previous history of cancer diagnosis in our analysis. exclusion criteria: * patients age \<18 year, incarcerated patients, and patients whose medical decisions are made by proxy will be excluded.
complicated appendicitis during the covid-19 pandemic in jordan

Conditions: COVID-19; Complicated Appendicitis

Summary: comparing the incidence of complicated appendicitis between two groups, the pandemic and pre-pandemic groups.

the investigators have retrospectively investigated data on acute appendicitis cases. two groups were established, the first group was the pandemic group, which included patients who presented to the hospital during the period of acute restrictions and shutdowns extending from the 17th of march to the 6th of june 2020, and the pre-pandemic group which represents the same period in the previous year, the aim was to assess the incidence of complicated appendicitis during the covid-19 pandemic in jordan university hospital

Eligibility criteria:
inclusion criteria: * any patient that presented with appendicitis and underwent an appendectomy at the university of jordan hospital during the specified time periods (march 2019-december 2020) exclusion criteria: * incomplete data record.
moderna vaccine mrna-1345 observational respiratory syncytial virus (rsv) study

Conditions: Respiratory Syncytial Virus

Summary: the main goal of this observational study is to describe the health and economic outcomes associated with use of the moderna mrna-1345 vaccine.

this study will evaluate real-world data (rwd) and data from eligible united states (us) based participants from study mrna-1345-p301 (nct05127434) for additional health and economic outcomes such as hospitalizations, healthcare resource utilization, disease exacerbations, and costs, associated with usage of the mrna-1345 vaccine. the results from the current study (mrna-1345-p901) are intended to complement the results from the mrna-1345-p301 study. no interventions will be administered during the current study (mrna-1345-p901).

Eligibility criteria:
inclusion criteria: p901 inclusion criteria: * must be a participant in p301 * must be based in the us * must provide informed consent for p901 p301 key inclusion criteria: * adults who are primarily responsible for self-care and activities of daily living. * participants may have one or more chronic medical diagnoses (specifically chronic heart failure and chronic obstructive pulmonary disease) but should be medically stable in the opinion of the investigator. * body mass index from ≥18 kilograms (kg)/square meter (m\^2) to ≤35 kg/m\^2. exclusion criteria: p901 exclusion criteria: * receipt of any future licensed rsv vaccine at baseline. * receipt of any future licensed rsv vaccines during the study follow-up period will result in censorship on the date the vaccine was received. all inclusion and exclusion criteria from p301 that are available in the rwd will be applied to the rwd controls, if built. p301 key exclusion criteria: * participation in another clinical research study where participant has received an investigational product (drug/biologic/device) within 45 days before the planned date of the day 1 vaccination. * prior participation in research involving receipt of any investigational rsv product (drug/biologic/device). * history of a serious reaction to any prior vaccination or guillain-barré syndrome within 6 weeks of any prior influenza immunization. * received or plans to receive any non-study vaccine within 28 days before or after the day 1 study injection. the exceptions are seasonal influenza vaccines, pneumococcal vaccines, or authorized or approved vaccines for the prevention of covid-19 (regardless of type of vaccine), which are not permitted within 14 days before or after the day 1 study injection. efforts should be made to space study injection and covid-19 vaccination by at least 7 and preferably 14 days, but covid-19 vaccination should not be delayed. other inclusion and/or exclusion criteria may apply.

Keywords: viral diseases messenger rna moderna mrna-1345 effectiveness vaccines
molecular analysis in peritoneal washing citology for locally advanced gastric cancer

Conditions: Gastric Cancer; Polymerase Chain Reaction

Summary: gastric carcinoma is a disease with a high mortality. peritoneal washing cytology has a recognized prognostic utility. however sensibility of this study is not appropriate. studies with pcr (polymerase chain retrotranscription) can increase sensibility and accurate staging information. objective: to analyze the sensibility and specificity of the expression of ck20, cea and ber-ep4 with pcr technique in peritoneal washings of advanced gastric carcinoma without clinical evidence of peritoneal carcinomatosis. methodology: retrotranscription analysis (rt-pcr) and quantitative pcr (qpcr) of ck20, cea and ber-ep4 in peritoneal washing. test the feasibility of qpcr with this new marker (ber-ep4). comparison of the results with data obtained with conventional cytology. study of peritoneal recurrence.


Eligibility criteria:
inclusion criteria: * patients with resectable advanced gastric cancer * informed consent exclusion criteria: * macroscopic peritoneal carcinomatosis * non operable patients

Keywords: polymerase chain reaction gastric cancer citology peritoneal washing ck20 cea ber-ep4
active mmp-8 in oral fluid for the detection of oral and oropharyngeal cancer

Conditions: Oropharyngeal Cancers; Biomarker in Early Diagnosis; Oral Cancer , Oral Squamous Cell Carcinoma, Oral Cavity Cancer; Periodontal Diseases

Summary: the goal of this observational study is to evaluate whether the active-matrix metalloproteinase-8 (ammp-8) mouth-rinse test can help detect oral and oropharyngeal cancers. researchers measured ammp-8 levels in mouth-rinse samples collected from 77 cancer participants and 50 non-cancer participants in a clinical setting. the main question this study seeks to answer: can the ammp-8 mouth-rinse test accurately identify and differentiate cancer participants from non-cancer participants in real-time?

the goal of this prospective study is to evaluate whether the active-matrix metalloproteinase-8 (ammp-8) mouth-rinse test can detect and differentiate 72 oral and oropharyngeal cancers from 50 control participants. in sampling process patients were asked to pre-rinse with tap water for 30 s. after one-minute wait, they were asked to rinse their mouth 30 s with 5 ml of distilled water provided in the test kit and to spit it out in a sterile measuring cup. the sample solution were poured into the opening of the test cassette placed on the test system (oralyzer®) for quantitative results. after obtaining the quantitative results in 5-6 min, the cassette was promptly removed to conduct the qualitative evaluation (periosafe®). the expression of ammp-8 was compared with various factors, including age, sex, smoking status, periodontitis, tumor size, nodal or distal metastases, cancer stage, histological grade, and tumor site. statistical analysis was performed to evaluate these relationships.

Eligibility criteria:
inclusion criteria: * biopsy-confirmed oral or oropharyngeal cancer identified by the following international classification of diseases (icd-10) codes: c00-c06, c08-c10, c13, and c32 according to the american joint committee on cancer (ajcc) 8th edition * adult exclusion criteria: * in-situ cancer * previous cancer diagnosis within five years prior to the examination * use of tetracyclines at the time of sampling * did not follow the manufacturer's instructions prior to the mouth-rinse sample (i.e. brushing teeth before sampling)

Keywords: ammp-8 matrix metalloproteinase cancer carcinoma oral oropharyngeal mouthrinse
relationship between protein biomarkers in cerebrospinal fluid and alzheimer&apos;s disease in patients with depression

Conditions: Alzheimer's Disease

Summary: it is currently accepted that depression during midlife is a risk factor for alzheimer's disease (ad). furthermore, several prospective population studies have demonstrated that depression is an independent risk factor for incident dementia of different types (e.g. vascular, mixed, alzheimer's disease). however, it is not clear, what are the mechanisms that link depression and dementia, and if depression can be a prodromal manifestation of ad. there are also studies that suggest that depression could be an initial sign of ad. objective: 1. demonstrate that late life depression (over 60 years of age) constitutes the first manifestation of ad. 2. define by rating scales and life stressors have differential risk profiles evolutionary ad. 3. to study the relationship between the subtypes of depression and csf biomarkers, neurophycological test and evolution to ad.

groups of subjects: patients with recent apparition of late life depression without fulfilling the dementia criteria (global deterioration scale, gds, stages 1, 2 and 3). a longitudinal, prospective population study with two years follow-up. a cohort of will be included in the study. the patient's depression will be defined and categorized according to its severity (yesavage scale), whether it's endogenous or reactive (holmes and rahe scale) and taking into account the patient's medical history of depression. there will be a prospective follow-up of conversion to dementia (starting from gds stage 4). it will be considered that dementia corresponds to ad if the biological markers of lcr present typical changes of ad at the moment of inclusion (beta amyloid low and p-tau high). it will be studied if there's any correlation between the clinically defined depression types and a high risk of progression to dementia and especially to ad.

Eligibility criteria:
inclusion criteria: * \>= 60 years. * gds (reisberg gobal dementia scale) of 2 to 3. * geriatric depression scale of yesavage \>=12. * history of previous depressive episodes resolved, but the emotional situation 15 months before inclusion, necessarily have to be normal. exclusion criteria: * established dementia of any cause, or secondary degenerative dementia of any origin * primary diagnosis of cognitive impairment with psychiatric illness (schizophrenia , bipolar disorder, personality disorders ... ) * dual diagnosis of chronic depression, dysthymia more than 15 months duration, or major depression with psychotic or atypical symptoms * neuroimaging with significant chronic vascular involvement * to take drugs with known side effects on cognition and it is suspected that the neuropsychological deficits. * moderate or severe sensory deprivation or functional illiteracy in the neuropsychological study can not be performed * neoplastic diseasescontraindication to performing a lumbar puncture

Keywords: alzheimer's disease biomarkers depression dementia cerebrospinal fluid neuropsychological
stellate ganglion block can cause enhanced recovery after coronary arteries bypass grafting surgery

Conditions: Ischemic Heart Disease

Summary: the effects of sgb on the cardiovascular system remain controversial since the cardiac sympathetic nerves pass through the stellate ganglion. sgb is expected to have an ameliorative effect on impaired coronary circulation and cardiac function and thus to be well suited to the treatment of angina pectoris and myocardial infarction

investigators chose left sgb being safer with regards conductivity changes when compared to right sgb, in the present study investigators are trying to examine and compare whether coronary reperfusion in patients undergoing coronary artery bypass grafting who were subject to ultrasound guided left stellate ganglion block (sgb ) performed in the induction of anesthesia could decrease post cardiopulmonary bypass ischemic changes, pulmonary hypertension and right ventricular dysfunction leading to enhanced recovery. place of work: ain shams university hospitals cardiovascular surgery academy, cairo, egypt. number and selection of participants: 40 participants, 20 in each group (2 groups).

Eligibility criteria:
inclusion criteria: ischemic heart disease patients age above 18 years exclusion criteria: allergy to la, severe copd
phytoestrogens and colonic adenomatous polyps

Conditions: Intestinal Polyps

Summary: introduction: the data obtained by experimental studies about the influence of phytoestrogens on colorectal cancer (crc) have been very promising. on the other hand, clinical trials have produced conflicting results. the literature suggests that some subclasses of phytoestrogens may have protective effects against crc and colon adenomas, but most of these results come from population studies based on the dietary intake of phytoestrogens. on these premises, it is possible to hypothesize that the variability of the data reported in the literature may be due to the fact that the real absorption of phytoestrogens (by assessing their concentration in the serum or urine) and/or the ability of the single individual of producing equol was not evaluated. purpose: in the present study, the association between the phytoestrogens intake and the prevalence of colon adenomas was evaluated not only on the basis of the simply dietary intake but also on the measurement their intestinal absorption. moreover, a specific evaluation of equol production by the intestinal flora was performed. finally, intestinal bacteria involved in equol production were evaluated.

materials and methods: patients with sporadic colon adenomas were enrolled in group i (case) and patients without sporadic colorectal adenomas matched for sex, age and bmi were enrolled in group ii (control). all participants underwent the following evaluations: bmi, dietary history (for quantitative and qualitative analysis of dietary habits), quantitative analysis of phytoestrogens (by dietary questionnaires), medications (chronic assumption of aspirin at low doses), characteristics of the polyps (for a calculation the cancer risk), analysis of urinary excretion of phytoestrogens \[by high pressure liquid chromatography (hplc)\] and intestinal flora \[by mass spectrometry with matrix assisted laser desorption ionization time-of-flight (maldi-tof) technology\]. at the enrolment, patients will be invited to assume a standard quantitative of phytoestrogens at 8:00 a.am. and collect both a fecal sample and the urine of the following 24 hrs.

Eligibility criteria:
inclusion criteria: * subjects of both sexes aged between 50 and 75 years * colonoscopy within 3 months from the study evaluation exclusion criteria: * age \ 75 years * previous diagnosis of colon cancer or inflammatory bowel diseases (ibd) * hereditary intestinal tumors (fap, hnpcc, ...) * ongoing infections * intake, in the last 4 weeks, of drugs that alter the intestinal bacterial flora * creatinine clearance below 60 ml/min * liver failure

Keywords: phytoestrogens isoflavones adenomatous polyps microbiome
test of long-term safety and efficacy of sirolimus-permanent-polymer eluting stent (cypher)- and sirolimus-polymer-free eluting stents (pps/pfs) assessed by optical coherence tomography

Conditions: Coronary Heart Disease

Summary: the objective of this pilot study is to compare the pfs-eluting stent (isar rapa g1) with the pps-eluting stent (cypher®) regarding uncovered stent strut segments at 5 years.

the mid-term efficacy of drug-eluting stents has been well-established, but there is an ongoing debate on the potential of an increased incidence of late stent thrombosis, particularly after discontinuation of thienopyridine therapy, as well as of delayed onset of restenosis or catch-up phenomenon with permanent polymer-based des. the extent of strut coverage with reduction of exposed thrombogenic material has been shown to be associated with the inflammatory reaction grade and with the incidence of stent thrombosis. the optical coherence tomography (oct) is an intravascular imaging modality based on light. the principle is similar to intravascular ultrasound, but due to the much shorter wave length of light, it offers a much better resolution up to 10µm, enabling the exact determination of strut coverage, neointimal thickness, vessel size, presence of dissections, and even the presence of inflammation. patients who received a polymer-free or a permanent-polymer sirolimus-eluting stent about 5 years ago without in-segment intervention since, will be evaluated by oct regarding the healing pattern and the late lumen loss of the stent.

Eligibility criteria:
inclusion criteria: * patients older than age 18 with with previous implantation of polymer-free or permanent-polymer sirolimus-eluting stents 5 years ago due to ischemic symptoms or evidence of myocardial ischemia in the presence of ≥ 50% stenosis located in native coronary vessels. * written, informed consent by the patient or her/his legally-authorized representative for participation in the study and assessment by oct. * in women with childbearing potential a negative pregnancy test is mandatory. exclusion criteria: * intervention in the segment of the study stent after the index procedure * target lesion located in the left main trunk. * in-stent restenosis with difficulty to pass the oct device * acute myocardial infarction * known allergy to the study medications: sirolimus, rapamycin, probucol or stainless steel. * pregnancy (present, suspected or planned) or positive pregnancy test. * patient's inability to fully cooperate with the study protocol.